{
"info": {
"nct_id": "NCT03589131",
"official_title": "Robotic-assisted Versus Conventional Laparoscopic Approach for Rectal Cancer Surgery, First Egyptian Academic Center Experience, Randomized Controlled Trial (RCT)",
"inclusion_criteria": "* histological diagnosis of adenocarcinoma of rectum\n* no anesthesiological contraindications to minimally invasive surgery\n* age 16 -75 years,\n* ASA ≤ 2 &\n* the procedures performed by the same surgical team.\nHealthy volunteers allowed\nMust have minimum age of 16 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Patients with metastatic disease,\n* malignant bowel obstruction (MBO) and\n* those with irresectable tumor",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* histological diagnosis of adenocarcinoma of rectum",
"criterions": [
{
"exact_snippets": "histological diagnosis of adenocarcinoma of rectum",
"criterion": "adenocarcinoma of rectum",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "histological"
}
]
}
]
},
{
"line": "* no anesthesiological contraindications to minimally invasive surgery",
"criterions": [
{
"exact_snippets": "no anesthesiological contraindications to minimally invasive surgery",
"criterion": "anesthesiological contraindications",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* age 16 -75 years,",
"criterions": [
{
"exact_snippets": "age 16 -75 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 16,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* ASA ≤ 2 &",
"criterions": [
{
"exact_snippets": "ASA ≤ 2",
"criterion": "ASA score",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* the procedures performed by the same surgical team.",
"criterions": [
{
"exact_snippets": "procedures performed by the same surgical team",
"criterion": "surgical team",
"requirements": [
{
"requirement_type": "consistency",
"expected_value": "same"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 16 Years",
"criterions": [
{
"exact_snippets": "minimum age of 16 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 16,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Patients with metastatic disease,",
"criterions": [
{
"exact_snippets": "metastatic disease",
"criterion": "metastatic disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* malignant bowel obstruction (MBO) and",
"criterions": [
{
"exact_snippets": "malignant bowel obstruction (MBO)",
"criterion": "malignant bowel obstruction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* those with irresectable tumor",
"criterions": [
{
"exact_snippets": "irresectable tumor",
"criterion": "tumor",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}